FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Therapies 59

Therapies Engineering Production FDA 59

The Premier Consulting Blog

OCTOBER 26, 2022

Development of the manufacturing process description The development of the MPD is an iterative process. The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assay development.

Production 40

Production Assay Development Clinical Supply Clinical Development 40

Drug Target Review

OCTOBER 10, 2024

Addressing unexpected manufacturing challenges, safety concerns, or efficacy issues in later stages can significantly delay clinical development and escalate costs. In conclusion, over-reliance on healthy donor material in cell therapy development creates a precarious foundation for clinical translation.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52